A report published on 13 October 2015 by the British Medical Journal has found that women who had the Essure device fitted as a method of sterilisation have a ten times greater risk of having to undergo a repeat operation compared to women who have undergone more conventional methods of sterilisation.
There are different procedures and methods of female sterilisation. Women can chose to have hysteroscopic sterilisation, where implants such as the Essure, which is a spring, are used to block the fallopian tubes to prevent the eggs reaching the womb. The insertion of the Essure does not require an incision as it can be inserted by a catheter through the vagina.
Alternative methods such as laparoscopic sterilisation involve a small incision in the abdomen under general anaesthetic so that the fallopian tubes can be cut and sewn shut or closed off using clips or rings.
The report looked at 8,000 women who had the Essure fitted and 44,000 women who underwent conventional sterilisation. Although both methods are effective forms of sterilisation and the number of unintended pregnancies was low for both procedures, women who had Essure had a substantially increased risk of reoperation due to experiencing complications such as pelvic pain and haemorrhage. There were also rare instances of the device puncturing organs, such as the bowel.
The report found that Essure was linked to an extra 21 repeat operations per 1,000 patients undergoing the procedure. Art Sedrakyan, a report author, told the BBC: “It may not sound many but this is a commonly done procedure so that makes it relevant.” He went on to advise: “Our study is very helpful. It shows how Essure compares with the main alternative, which means women can weigh the benefits and harms and regulators can make better decisions."
The manufacturer of Essure, Bayer, has advised that the safety of the device is backed up by evidence. A spokeswomen for the company said: “Women who have Essure receive a routine check-up three months after having the device fitted, this may partly explain why more in the study had follow-up surgery.” She also said: “As there is no confirmation test that could identify potential failure of a laparoscopic tubal ligation procedure, it stands to reason that the comparative reoperation rate would be lower."
The findings are worrying to women who have had the Essure fitted and to those considering methods of sterilisation. If a patient has any worries about a potential problem that might be attributed to the device, they can report their concerns to the Medicines and Healthcare products Regulatory Agency.
Georgina Blackwell of the Penningtons Manches clinical negligence team said: “It is always important that the benefits and risks of both of these procedures are discussed with patients when considering their opinions to enable them to make an informed decision.”